Label: WARRIOR RECTAL CARE- lidocaine 4%, phenylephrine hydrochloride 0.25% ointment
- NDC Code(s): 72839-071-01
- Packager: Derma Care Research Labs
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 19, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
For external and/or intrarectal use only.
When using this product do not exceed recommended daily dosage unless directed by a doctor.
Do not use this product if you have difficulty in urination due to enlargement of the prostate gland. Diabetes, heart disease, high blood pressure, thyroid disease. Presently taking a prescription for high blood pressure or depression.
Stop use and ask a doctor if condition worsens or does not improve within seven days, bleeding occurs. Introduction of applicator into the rectum causes additional pain.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Children under 12 years of age consult your pediatrician.
Adults: apply to affected area up to 4 times daily.
Clean affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use.
FOR INTRARECTAL USE: attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Thoroughly cleanse applicator after each use and replace cover.
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INACTIVE INGREDIENT
Aloe Barbadensis Leaf Extract, Calendula Officinalis Flower Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Glyceryl Caprylate, Helianthus Annuus (Sunflower) Seed Oil, Lysine HCl, Mineral Oil,
Olea Europaea (Olive) Fruit Oil, Petrolatum, Punica Granatum Extract, Retinyl Palmitate, Stearic Acid, Tocopheryl Acetate, Water - PREGNANCY OR BREAST FEEDING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WARRIOR RECTAL CARE
lidocaine 4%, phenylephrine hydrochloride 0.25% ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72839-071 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 0.25 g in 100 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) GLYCERIN (UNII: PDC6A3C0OX) ALOE (UNII: V5VD430YW9) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM) MINERAL OIL (UNII: T5L8T28FGP) MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0) OLIVE OIL (UNII: 6UYK2W1W1E) PETROLATUM (UNII: 4T6H12BN9U) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72839-071-01 1 in 1 CARTON 01/23/2023 1 28 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 01/23/2023 Labeler - Derma Care Research Labs (116817470) Registrant - Derma Care Research Labs (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs 116817470 manufacture(72839-071)
